About Huanling
Company profile
China and the West jointly innovate for win-win results
Huanling Pharmaceutical is an innovative drug development and commercialization company based in Shanghai, China, with offices in the United States and Hong Kong, China。We focus on unmet medical needs and develop new therapies for patients around the world。bwin信誉平台汇聚全球医药行业高素质人才，融合全球创新技术，依托全球优势资源，研究开发突破性的技术和产品，引领全球糖尿病医疗创新。
bwin信誉平台秉持“患者为先，创新为本，良药为民”的宗旨，通过“中西合璧、联合创新、共享共赢”的运营模式，实现人类健康发展的远大目标。
The company's core product Huatangning®(Doglietine tablets，dorzagliatin，HMS5552) targets the glucose sensor glucokinase，Improve glucose sensitivity in type 2 diabetes patients，Improve blood glucose homeostasis in patients，It received marketing approval from China's National Medical Products Administration (NMPA) on September 30, 2022，It is used alone or in combination with metformin，Treatment of adult type 2 diabetes。对于肾功能不全患者，无需调整剂量，是一款可用于不同程度的肾功能损伤（包括未进行透析的终末期肾损）的2型糖尿病患者的口服降糖药物。The company will work with Bayer to commercialize Huatangning ® in China for the benefit of diabetes patients and their families。
Doglietine is a total activator of allosteric glucokinase (GK)，It acts on glucokinase targets in islets, intestinal endocrine cells, and glucose storage and output organs such as the liver，Improves impaired glucose-stimulated insulin and GLP-1 secretion in patients with type 2 diabetes，And improve beta cell function，Reduces insulin resistance，To improve blood glucose homeostasis in type 2 diabetes patients，It can reshape the physiological regulation of blood glucose balance。
Clinical trials have shown that by repairing damaged glucokinase in patients with type 2 diabetes, glucose sensor function is repaired®It is expected to restore blood glucose homeostasis in patients with type 2 diabetes。Following the SEED study, Warneck continued to explore the potential of doglietine for diabetes relief。During the study period, doglietine therapy achieved remission of diabetes discontinuation, with a 52-week remission rate of 65.2%。
展望未来，bwin信誉平台将在新产品上市、新市场开拓和新疾病领域三个维度实现从1到10 的发展，实现“中华引领医药创新”的美好愿景。
Development course
Hualing Pharmaceutical announced that doglietine was included in the national medical insurance drug list
Huanling Pharmaceutical announced the submission of an IND application to the US FDA for its second generation glucokinase activator (second generation GKA)
Huatangning ®, the world's first new drug, has been approved by the National Drug Administration (NMPA) of China。
国际顶级医学刊物《信誉搏彩平台》（Nature Medicine）杂志同时在线发表2篇关于多格列艾汀两项III期注册临床研究结果的同行评议论文。
Researchers release important study on Doglietine diabetes remission
Dozaglia Etine NDA, the first new drug for diabetes, was accepted by NMPA
宣布dorzagliatin与二甲双胍联合用药III期注册临床研究(HMM0302)24周核心研究取得正面结果。
Announced successful completion of Phase III SEED study of dorzagliatin monotherapy (HMM0301)。
宣布HMS5552（dorzagliatin） 在未用药 2 型糖尿病患者中开展的单药治疗 III 期注册临床研究HMM0301达到主要疗效终点。
Wuhan branch established
Listed on Hong Kong Stock Exchange
The phase II results were published in the Lancet Diabetes andEndocrinology
Hualing Medical Beijing office put into operation
Phase III trials commenced in China
Phase III clinical study of HMS5552 was officially initiated
HMS5552 was approved by the State Food and Drug Administration as a pilot variety of the drug marketing authorization holder system
HMS5552 successfully completed Phase II clinical study
The Phase II/III clinical study approval for HMS5552 was approved, initiating patient enrollment
The US Food and Drug Administration approved the HMS5552 project to enter the Phase I clinical study (the first time to enter the US patient)
HMS5552 successfully completed the clinical phase I c study to achieve clinical validation of drug mechanism and pharmacodynamics
HMS5552成功完成临床Ⅰb期糖尿病患者多次口服用药的安全、耐受性，药代动力学和药效学研究
HMS5552 successfully completed the safety, tolerability and pharmacokinetics study of a single oral administration of HMS5552 in healthy patients in the clinical phase Ⅰ
The original diabetes drug HMS5552 entered the clinical research project for the first time
HMS5552 was approved by the State Food and Drug Administration for clinical research of new diabetes drugs
中枢神经系统（CNS）疾病项目完成临床前药效学以及安全评价并向全世界知识产权局递交第一代mGluR5 NAM/PCT发明专利申请
The application materials for clinical research of the original diabetes drug HMS5552 were submitted to the State Food and Drug Administration
The "Chinese Medicine - Diabetes Original New Drug" project was launched in Zhangjiang, Shanghai
The introduction of global market licenses for innovative diabetes drugs from multinational pharmaceutical companies
Hualing Medical Technology (Shanghai) Co., Ltd. was established
Business partner
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